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The Flexitouch System and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as:

• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• · Edema following trauma and sports injuries
• · Post immobilization edema
• · Venous insufficiency
• · Reducing wound healing time
  · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers

The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

The Flexitouch system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide pneumatic compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller. Air passes through the tubes, delivering treatment via the sequential inflation of up to 32 air chambers in the garments.

The provided document does not contain information related to a study that uses a test set, expert adjudication, MRMC studies, or specific performance metrics with acceptance criteria for an AI/software-based medical device.

The document is a 510(k) premarket notification for the Flexitouch® System, Model PD32-G3, a pneumatic compression device. It focuses on demonstrating substantial equivalence to a predicate device (Flexitouch® System, K153311) based on existing technology characteristics and non-clinical performance testing.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies.

The document explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices." This implies that the device's performance was not evaluated through a study involving human subjects or the kind of data analysis typically associated with AI/software device validation.

If the device were an AI/software product, the information you requested would be critical. However, for a physical medical device like the Flexitouch® System, substantial equivalence is often shown through comparisons of design, materials, electrical safety, software validation (general, not AI-specific), biocompatibility, and physical performance tests like pressure verification.

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The Flexitouch® system and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as:

• Lymphedema
• Primary lymphedema
• · Post mastectomy edema
• · Edema following trauma and sports injuries
• · Post immobilization edema
• · Venous insufficiencies
• · Reducing wound healing time
  · Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers

The Flexitouch® system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

The Flexitouch® system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around an affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller.

Here's a summary of the acceptance criteria and study information for the Flexitouch System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria in a table format. Instead, it broadly states that "The test results verify that the safety and performance for the device met all pre-specified performance criteria and is substantially equivalent to the predicate device for its intended use."

However, based on the "Summary of Performance Testing" and "Summary of Clinical Evaluation", we can infer the reported device performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for the Clinical Study (Test Set): Not explicitly stated, but described as a "single-arm, single-center study."
• Data Provenance: Prospective, single-center study. The country of origin is not specified but given the FDA submission, it's typically a U.S.-based study or studies conducted under FDA guidelines.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish "ground truth" for the clinical study directly. The assessment of lymphedema reduction (facial composite score) and adverse events would typically be performed by the medical professionals conducting the study. No specific number or qualifications of clinicians involved in assessing outcomes are provided beyond the study being supervised by "medical professionals."

4. Adjudication Method for the Test Set

Not applicable. This was a single-arm study evaluating the device's performance, not a comparative study requiring adjudication of diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a therapeutic system (compression therapy for lymphedema), not an AI-based diagnostic image analysis tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Flexitouch system is a physical medical device (pneumatic compression system) with software to control its operation, not a standalone algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical study, the "ground truth" for efficacy was based on outcomes data, specifically:

• Reduction in head/neck lymphedema (measured by "facial composite score").
• Patient-reported comfort and ease of use.
• Monitoring of device-related adverse events.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/Machine Learning algorithm that requires a separate training set. The software mentioned would have undergone typical software verification and validation, not model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, this is not an AI/ML device requiring a training set with established ground truth.

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The Flexitouch® system is intended for use by medical professionals and patients at home who are under medical supervision in treating many conditions such as:

• Primary lymphedema .
• Post mastectomy edema .
• Edema following trauma and sports issues .
• Post immobilization edema .
• Venous insufficiencies .
• Lymphedema .
• . Reducing wound healing time
• Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; . arterial and diabetic leg ulcers

The Flexitouch® system is a prescription pneumatic compression system consisting of a garment set and a pneumatic sequential controller. The garments are wrapped around the affected body regions so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression in the treated areas.

The provided text is a 510(k) summary for the Flexitouch® system. It outlines the device's characteristics and its comparison to a predicate device but does not contain information about acceptance criteria or a specific study designed to prove the device meets acceptance criteria in the format typically associated with diagnostic or AI/ML device validation.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This means the primary "study" is a comparison to an already legally marketed device, asserting that the new device is as safe and effective as the existing one.

Therefore, the following table and explanations are derived from the available information and will highlight the absence of certain requested details, as they are not typically part of a 510(k) summary for this type of device.

Acceptance Criteria and Device Performance

Study Details (Based on available 510(k) summary)

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not specified. The document refers to "Comparative performance testing and evaluation" but does not provide details on the number of devices, components, or clinical subjects involved in these tests. For a device like a pneumatic compression system, "performance testing" might involve bench testing or engineering verification rather than a traditional clinical test set of patient data.
   • Data provenance: Not specified. Given the nature of a 510(k) for a physical medical device, the "data" would likely originate from internal engineering and manufacturing tests. No information about country of origin, retrospective or prospective data is provided, as these terms are more relevant to clinical studies involving patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable and not provided. The "ground truth" for this type of device is typically established by engineering specifications, safety standards, and functional requirements, rather than expert clinical consensus on a "test set" of patient data. Performance is assessed against these established technical benchmarks.

3. Adjudication method for the test set:

   • Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert readers resolve discrepancies in interpretations of medical images or diagnoses. This type of review is not relevant for the engineering and functional tests reported in this 510(k).

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Flexitouch® system is a pneumatic compression device, not a diagnostic AI tool, so this type of study is irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This question is not applicable to the Flexitouch® system. It is a physical medical device, not an algorithm. The "software validation testing" mentioned would focus on the correct functioning of the embedded software within the device to control its pneumatic operations, not on its performance as a standalone interpretive algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" in this context is implicitly engineering specifications, international safety standards, and the validated performance of the predicate device. For example, "software validation testing" would compare the software's output to its design requirements. "Device performance testing" would compare the physical performance (e.g., pressure, cycle times) to specified ranges and the predicate device's performance.

7. The sample size for the training set:

   • Not applicable and not provided. This device does not use a "training set" in the machine learning sense. Its functionality is based on established engineering principles and control logic, not learned from data.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, there is no ground truth established for it.

Ask a specific question about this device

The Flexitouch system is intended for use by medical professionals and patients who are under medical supervision, in treating many conditions such as:

• . Primary lymphedema
• Post mastectomy edema .
• . Edema following trauma and sports injuries
• . Post immobilization edema
• . Venous insufficiencies
• . Lymphedema.
• Reducing wound healing time .
• . Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers

The Flexitouch® System is a powered inflatable tube massager intended for medical purposes. The primary components of the System include a pneumatic sequential controller device that delivers air to garments with inflatable chambers to be worn over the patient's afflicted areas. The inflation and deflation of the chambers simulates kneading and stroking of the tissues with the hands in order to increase circulation.

I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for the Flexitouch® System, a powered inflatable tube massager. It primarily focuses on demonstrating substantial equivalence to predicate devices for expanding its indications for use.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Details of any specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods) used to prove the device meets acceptance criteria.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample sizes for training and test sets.

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